ES2227347T3 - SET FOR CATETER INTRODUCTION THAT INCLUDES NEEDLE PROTECTION. - Google Patents

Abstract

A catheter insertion unit, comprising: a needle receptacle (14) and a hollow needle (12) fixed thereto, which is provided, near the tip of the needle, of coupling means (50), a catheter receptacle (18), which comprises a catheter (16) attached thereto, a safety barrier or lining (20; 110) for the tip of the needle, arranged around the needle and which is capable of sliding from a position ready for operation to a safety position, in which the safety barrier covers the needle tip, and coupling means (58, 78), located in the safety barrier (20; 110), in which the coupling means (50) of the needle (12) are coupled with the coupling means (58, 78) arranged in the safety barrier (20; 110) when the needle is removed from the receptacle (18) of the catheter, so that the safety barrier adopts the safety position on the tip of the guja, in which the safety barrier has been made as an elastic fastener (28, 84), and in which elastic arms (43, 44) of this elastic fastener cover the tip of the needle in the safety position , characterized in that the elastic fastener element is arranged, at least in part, in the position ready for operation, within an enclosure wall or enclosure (66) of the needle receptacle (14), while the elastic arms opposites (43, 44; 92) of the elastic fastener element are removably or detachably coupled to the outer circumference of the receptacle (18) of the catheter.

Description

Catheter introduction set that It includes needle protection.

The invention relates to a unit for the introduction of a catheter, according to the preamble of the claim 1.

Such a catheter introduction unit is known. of US-A-6,117,108. At US-A-6,004,294 is described a needle guard, located between a catheter receptacle and a needle receptacle The needle guard attaches or attaches to the needle receptacle by means of arms that extend through on the outer side of the needle receptacle, while fingers, which include projections directed radially inward, are couple with the outer circumference of the catheter receptacle, to order to maintain or hold the introduction needle assembly in conjunction with the catheter assembly.

The document US-A-5,601,536 describes a cover needle tip comprising a cylindrical portion that is inserted into the needle receptacle in the operational or ready position for operation, as a coating portion or terminal wrap of the needle tip cover fits into the outer circumference of the catheter receptacle.

The document US-A-6,117,108, the prior art closer, describes an intravenous safety catheter of elastic fastener element, in which the fastener element is placed inside the catheter receptacle in position ready for operation, and a cylindrical portion is inserted of the needle receptacle in the catheter receptacle.

The medical care of individuals requires a extensive use of catheter devices in order to extract blood samples, administer medications intravenously (IV), and for the introduction or extraction of other fluids. The use of a catheter device ("catheter") typically involves first inserting a combination of needle and plastic catheter in a patient's vein and remove to then the needle in order to leave only the catheter of plastic in the vein. The needle removed is then typically discarded

In order to help the procedure of discarded and contribute to prevent medical assistance staff suffer injuries when coming into contact with the exposed tip of a used needle, protections or barriers of needle intended to block or lock the needle tip once that this has been extracted. Certainly with infectious diseases life-threatening such as Immunodeficiency Syndrome Acquired (AIDS) and hepatitis, which can be transmitted to through the exchange of body fluids for contact accidental with the needle tip of a used needle, it has never been more importantly protection against a needle stick.

Safety catheter devices commercially available can generally be grouped into three basic categories: (1) those that include an activation mechanism in order to hide the needle removed within a protection of needle; (2) those that require the placement of a barrier needle independent; and (3) those that include protection slide to be placed manually in the distal position, or farther away, over the used needle. Despite his commendable intentions, most of these catheter devices Security suffer from some disadvantages. Among other things, some require an additional step beyond the steps of normal insertion and withdrawal, and / or require complicated parts additional in order to ensure that the needle barrier and the catheter remain fixed during the procedure of extraction.

In the first category there are several systems different conventional available, with a common design that it serves as a needle guard, loaded by a spring and locked by friction in order to automatically engage with the tip of the needle when the needle is removed from the catheter. Yes well these devices can be considered suitable, a user can apply unknowingly enough force, during the procedure of the extraction, to overcome the friction coupling in the device, such that the spring loaded protection can slide out of the distal end of the needle and leave the bare needle tip.

Another example of spring needle protection of the prior art of the first category makes use of a slightly expanded or extended portion of the needle tip (such as a ledge or a flanged surface) in order to prevent the protection of a needle from sliding out of the end distal of the needle once the protection has been attached. In Many of these designs, the needle guard is placed first to friction in the catheter body, before being used or inserted into a patient's vein. But nevertheless, after insertion and during the extraction procedure, the protection, placed on friction, presents the tendency to disengage from the catheter body before the complete separation of the needle from the catheter. When this occurs, the tip of the needle has already been exposed, because at the early separation of the spring protection.

In conventional devices of the art previous of the second and third categories, there is a certain number of different designs that include needle guards, either with an elastic fastener element adjustment device or well with a friction adjustment device. A protection of needle of this type, well placed directly on the tip of the needle or is likely to move from the base of the needle to the tip of the needle along the longitudinal direction of the needle. In this last embodiment, a user can do manually slide the needle guard in the direction of the needle tip, in order to attach the needle guard in the same. However, these manually operated designs require the user to either slide or apply the needle guard over the needle tip by hand, thereby significantly increases the risk of unintended contact With the tip of the needle.

In another set of technique catheter above, the safety barrier is configured so that it seat in the catheter receptacle until the needle has been withdrawal. Once the needle has been removed, the barrier of security is unlocked or released from the catheter receptacle to move on to block the tip of the needle. This design, however, adds an adverse intrinsic drag effect between the needle and the safety barrier, as the needle is removed. This drag is undesirable because it can generate a movement of non-uniform extraction.

Consequently, the need for a catheter assembly that reduces the risk of decoupling early, by maintaining both the needle barrier and the body of the catheter attached during the extraction procedure, and that disengage simultaneously and automatically from the catheter body with a substantially zero adverse drag effect, and block the tip of the needle once the procedure has been completed Extraction

This is achieved through the features of the characterizing part of claim 1.

In accordance with the present invention, provides a set design for the introduction of a catheter, which automatically displaces the elastic fastener from the needle to a position where the tip of the needle when detaching the needle from the catheter body. This action occurs as a direct consequence of needle removal of the catheter bore, without the activation of any additional mechanism to complete the extraction procedure of the needle.

The catheter introduction set according with the present invention comprises a needle and a receptacle of needle, a catheter and a catheter receptacle, and a set of elastic security fastener. The needle has a elongated stem defining a longitudinal axis. The needle includes also a needle tip and has a proximal end, or more close, secured to the needle receptacle by means conventional. The needle further comprises a distal end, which is close to the tip of the needle, and is provided with a needle stop located between the proximal and distal ends. He needle stop serves as a limiting feature intended for limit the movement of the elastic security fastener when the elastic security fastener element comes into contact with the same. The catheter is fixedly secured to the receptacle of the catheter with the use of conventional means, and is mounted so sliding over a substantial portion of the needle.

The elastic fastener element set of security comprises a needle locking mechanism intended to block the tip of the needle, as well as a retention mechanism, whose purpose is to prevent the elastic security fastener separate from the needle. The elastic security fastener It is slidably mounted on the needle and sits generally between the catheter receptacle and the receptacle of the needle, and, in an exemplary embodiment, is removably secured or detachable to both receptacles. The elastic fastener security has been configured so that it is mounted so sliding over the needle stem, and has an interval or sliding margin that is limited, to one side, by the top of needle and, on the other side, by the needle receptacle.

Brief description of the drawings

These and other features and advantages of the present invention will be appreciated as it is understood better in relation to memory, claims and drawings which are accompanied, in which:

Figure 1a is a top plan view, in cross section and semi-schematic, of a set of needle provided in accordance with the principles of this invention;

Figure 1b is a top plan view, in cross section and semi-schematic, of a set for the introduction of a catheter, in an operative position or ready for operation and provided in accordance with principles of this invention;

Figure 1c is a top plan view and semi-schematic of a fastener element of safety for a needle, which is provided in accordance with the principles of this invention;

Figure 1d is a top plan view and semi-schematic of a fastener element of security activated, provided in accordance with the principles of this invention;

Figure 1e is a view semi-schematic from one end of the element safety bra, taken along the A-A line of Figure 1c;

Figure 1a is a top plan view, in cross section and semi-schematic, of a set of alternative needle provided in accordance with the principles of this invention;

Figure 2b is a top plan view, in cross section and semi-schematic, of a set alternative for the introduction of a catheter, in a position operational and provided in accordance with the principles of this invention;

Figure 2c is a side view, in section transversal and semi-schematic of the set of catheter introduction shown in Figure 2b;

Figure 2d is a view from one end and semi-schematic safety fastener element needle, taken along the C-C line of the Figure 2e;

Figure 2e is a top plan view and semi-schematic of a fastener element of needle safety, provided in accordance with the principles of this invention;

Figure 2f is a side view and semi-schematic safety fastener element needle, taken along line B-B of the Figure 2e;

Figure 2g is a top plan view and semi-schematic of a fastener element of security activated, which is provided in accordance with the principles of this invention;

Figure 3 is a top plan view, in cross section and semi-schematic, of another alternative set for the introduction of a catheter, provided in accordance with the principles of this invention; Y

Figure 3 is a view from one end, in cross section and semi-schematic, of a catheter, taken along the D-D line of Figure 3.

Detailed description

It is intended that the detailed description be exposes in what follows in relation to the accompanying drawings constitutes a description of the preferred embodiments in the news for the set for the introduction of a catheter security provided in accordance with the present invention, and it is not intended to represent the only ways in which The invention can be constructed or used. The description exposes the characteristics and the steps for the construction and the use of the safety catheter introduction set of the present invention, in relation to the embodiments that are illustrate. Also, as indicated here elsewhere, it It is intended that the same reference numbers designate elements or same or similar characteristics.

Referring then to the Figures 1a and 1b, shown in them and describes a set of catheter introduction provided by way of example and agreement with the practice of the present invention, which is designated generally with numerical reference 10 (Figure 1b). Set 10 catheter introduction shown therein comprises a needle assembly 11 (Figure 1a), which includes a needle introduction 12, mounted on a needle receptacle 14 in one way conventional, as well as a catheter body 15 (Figure 1b), which includes a flexible tubular catheter 16, mounted in a receptacle catheter plastic 18, also in a conventional manner (Figure 1 B). The catheter introduction assembly 10 comprises additionally an elastic security fastener or a needle clamp element 20 which is slidably mounted on the needle 12 and secured in a removable or detachable manner in the inside the needle receptacle 14, in the holding chamber or bore 22, at the distal end of the needle receptacle 14.

Needle 12 additionally comprises a rod of needle 24, a needle tip 26, located at the most extreme remote or distal 28 of the needle, and a needle inlet 30, located at the nearest or proximal end 32 of the needle, which, in a embodiment provided by way of example, extends in the inside a flow drive chamber 34, located in the proximal end of the needle receptacle 14. In an embodiment that by way of example, the needle receptacle 14 is provided additionally comprises a pair of lateral grooves and diametrically opposed 36, which are located distally in the clamping bore 22. The lateral grooves 36 allow access to a pair of spring or elastic arms that extend out of the holding core 22, in order to be removably coupled to the catheter receptacle, as further described further ahead. In this way, it is possible to conceive the fastener element needle as provided with a first portion or proximal end, which sits within the bore 22, and a second portion or end distal, which extends outside the bore to engage the catheter receptacle 18.

The catheter introduction set has three positions, a pre-operative position (Figure 1a), a operational position or ready for operation (Figure 1b) and a extraction position or fully retracted (Figure 1d). In the pre-operative position, the elastic fastener element of security 20 sits inside the clamping bore 22, with its proximal end 38 in contact with the proximal end 40 of the clamp. However, it is understood that the contact mentioned is not essential and that, alternatively, instead of simply rest inside the holding core 22, the elastic security fastener element 20 can be attached slightly by friction on the inner diameter of the bore of fastener 22. As discussed further below, this lightweight friction coupling, if used, must require a less force to disengage than the force needed to separate the elastic security fastener element 20 from the catheter receptacle 18. In this way, the fastener element elastic 20 will be disengaged from the needle receptacle 14 as the needle is removed from the patient, before the element elastic fastener 20 is disengaged from catheter receptacle 18. In the pre-operative position, the elastic fastener safety 20, comprising a distal end 42, two arms elongated elastics 43, 44, two distal end walls 46 and a elastic flange 48 on each of the distal end walls, or elastic fingers 46, is loaded in a first position and enters contact with the needle rod 24 with its two flanges elastic 48.

Needle 12 additionally comprises a stop of needle 50 (which is also commonly referred to as lobe, overhang or bulge; and referred to here in set as "needle stop"), arranged along the needle length 12, between the proximal 32 and distal ends 28, and preferably near the distal end 28 of the needle 12. In the embodiment provided by way of example, the needle stop 50 has an outline that is different from the needle outline 12, which has a uniform outside diameter throughout the stem 24. The needle stop 50 may comprise a portion beaded that is formed by beading the needle with the use of techniques known beading. In the flanged portion 50, the diameter of the needle stem is consequently different from the diameter uniform outside. In this way, according to one embodiment, the needle stop 50 has a shape that extends from the diameter uniform outside of the stem. In other words, the needle stop It has a shape or dimension that is larger than the diameter uniform outside. As discussed further below, this larger dimension allows the needle stop 50 to engage a cavity or opening located at the proximal end of the fastener elastic security 20, and prevent the elastic fastener 20 move further along the stem 24.

In the position ready for operation (Figure 1b), a substantial portion of the needle 12, including the needle stop 50, sits or rests inside the catheter bore 16, but in such a way that the tip 26 of the needle protrudes beyond of the distal tip 52 or catheter opening 16. How to shows and is exposed further below, the element Elastic safety pin 20 needle is in contact with both the needle receptacle 14 and the receptacle 18 of the catheter Specifically, the proximal end 38 of the element safety fastener is placed inside the bore of fastener 22, while its elastic arms 43, 44 extend through the lateral grooves 36, so as to fit releasable the outer surface of the proximal end 54 of the catheter receptacle with elastic flanges 48.

A present may be used in the present invention. certain number of needle receptacle designs, as long as the needle 12 and the barrier or lining 20 of the needle tip can be held together and catheter receptacle 18 can dispose adjoining them. In one embodiment provided by way of example and shown in Figures 1a and 1b, the needle receptacle 14 comprises a molded body 62 in full or in one piece, which, as stated above previously, it defines an internal, cylindrical and axial needle passage, or flow drive chamber 34. Clamping bore 22 is coaxial with the flow drive chamber 34 and has a wall of support 64 at the proximal end 40 of the clamping bore 22. The elastic wall 58 of the elastic security fastener element 20 it is located within the holding bore 22 and is supported against the support wall 64.

The clamping bore 22 can have any proper design, as long as the barrier 20 of the tip of the Needle can be placed inside. In the embodiment that shown in Figures 1a and 1b, for example, the receptacle 14 of the needle has an enclosure wall or envelope 66 which defines in its inside the clamping bore 22. The clamping bore 22 has a diameter that is larger enough than the largest dimension of the proximal end 38 of the safety fastener element, of such so that the proximal end can be removed from it with the minimum resistance

In an embodiment provided by way of example of catheter introduction set 10 that is provides in accordance with the practice of the present invention, the structure is configured with the purpose of facilitating the manipulation of the needle receptacle 14 between the thumb and the index and other fingers. For example, the envelope wall 66 of the needle receptacle 14 may include a stepped portion or a surface endowed with a certain texture or relief, in order to Provide a better grip. The body 62 of the receptacle of the Needle may be made of a transparent material, such as, for example, a transparent plastic, so that when the needle has been successfully inserted into a vein of a patient, it is possible to observe a backflow of blood that runs through the needle and goes inside the chamber of flow drive 34.

It is possible to use in the present invention any catheter receptacle 18 design, provided that the catheter 16 is held inside, needle passage is allowed 12 through it, and can be placed next to it the elastic security fastener element 20. Returning back to the Figure 1b, in an exemplary embodiment provided, the catheter receptacle 18 comprises a molded body 67 integrally, which defines an inner, axial catheter passage 68 and cylindrical, which has dimensions designed to accept and securely catheter 16 inside. They can form Conventional Luer connection threads 70 at the proximal end 54, in order to serve as a connection point for conduits of intravenous supply and similar elements, once it has been Completed the catheter insertion procedure. As stated additionally later, the connection of Luer 70 also makes anchor point times for elastic flanges 48 when the catheter assembly is the position ready for the functioning. As best shown in Figure 1b, once assembled, the outer surface of catheter receptacle 18 is coupled, at the Luer 70 connection, on the elastic fingers 46 of the elastic fastener element 20 and, more specifically, is detachably grasped by the elastic flanges 48 of the elastic fastener element 20.

Referring below to Figure 1c, is shown therein and an embodiment provided to example mode of an elastic security fastener element 20 which is provided in accordance with the practice of this invention. The elastic security fastener 20 can be made of an elastic metal such as stainless steel and, as It has been exposed in the above, it comprises two elastic arms elongated 43, 44, which have been formed by bending the elastic material to form a first set of two bending points 72. The elastic security fastener element 20 has also been folded into the distal end 42 to form a second set of two points bending 74. Assuming the width of the fastener elastic is the transverse or width measurement of the element elastic safety bra 20 shown in Figure 1e, the width of the upper elastic arm 43, as well as the width of the lower elastic arm 44, taken from a closely position near crossing point 76, to a position closely next of the second set of two bending points 60, is less than half the width of spring 20 when measured on the wall elastic 58. Preferably, the width of the elastic arms 43, 44 is such that there is a space between the arms at the point of cross 76, in order to allow the needle 12 to pass between them. Note that, although the lower elastic arm 44 is shown so which is shorter than the upper elastic arm 43, the arrangement Reverse can also provide a functional alternative. He elastic security fastener element 20 has a position relaxed or not charged when you are in the position you are indicated in Figure 1c. It is understood that the fastener element elastic 20 is slidably mounted on the needle 12 before the creation of the needle stop 50, or before it fix the needle receptacle 14.

Referring below to Figure 1e, an elevation view from one end of the elastic security fastener element 20, taken from the line A-A of Figure 1c. As shown, the elastic security fastener element comprises an opening circular 78, located centrally on the elastic wall 58. The opening 78 has a diameter that is slightly larger than the uniform diameter of the needle 12, although it is smaller than the width largest measure of needle stop 50. In this way, as shown in Figure 1d, the elastic end wall 58 is capable of slide around the stem 24 of the needle from between the stopper of needle 50 to the distal end 52 of the needle receptacle. Without However, the end wall 58 is prevented from moving in the direction distal beyond the needle stop 50, because the diameter of the opening 78 is smaller than the width of the needle stop.

In an alternative embodiment, opening 78 of the elastic fastener element 20 may have an oval shape, of star or other suitable form. Additionally, the elements elastic fasteners provided in accordance with this invention can have a single arm. In case it is used a single arm, such as one of the elastic arms 43 and 44, must incorporate a sufficient elastic force thereto, in such a way that, as the needle 12 is being removed, the element elastic bra 20 does not disengage catheter receptacle 18 before separation of the elastic needle clamp element 20 and of the clamping bore 22.

In addition to the features incorporated in the catheter receptacle described above, is possible to provide many other optional features. By For example, the catheter receptacle may comprise optional, a handle or handle and guide means intended to guide the needle 12 and catheter 16 inside the patient. The receptacle 18 of the catheter may also comprise an installed pin optionally inside the proximal end of the receptacle, in order to guide the needle 12 into the catheter 16 and the receptacle 18 of the catheter, or alignment means, intended to ensure that the catheter receptacle and needle receptacle remain oriented in a certain direction when assembled. it's possible also fix a vent or exhaust filter inside the end, since either from receptacle 18 of the catheter, or from receptacle 14 of the needle. Additionally, it can also be incorporated into the catheter receptacle 18 any suitable electronic circuit for the use of the catheter to measure or send signals to and / or from the patient.

The set 10 for catheter introduction it works by inserting the catheter introduction assembly, into its position ready for operation, in a patient's vein, and then removing the needle 12 while leaving the 16 catheter inserted into the vein. In an embodiment that is provides by way of example, the removal of the inserted needle is carried out by firmly grasping catheter receptacle 18, such as by gripping a pair of fins 56 installed in the same, and preventing the catheter receptacle from moving while simultaneously holding the needle through the receptacle 14 of the needle, to then extract the needle 12 by pulling the needle receptacle 14 or causing it to slide, in proximal sense, in order to separate the needle from the catheter.

As the needle 12 is removed in the direction proximal of the catheter 16, the needle clamp element 20 is uncouple the clamping bore 22. As the needle 12 is additionally removes proximally, the proximal end 38 of the needle clamp element slides with respect to the needle rod 24, until it comes into contact with the stopper of needle 50. More specifically, the cavity or opening 78 located in the elastic wall 58 slides with respect to the outer diameter uniform of the stem 24 until the opening 78 comes into contact with needle stop 50. As discussed above, the opening 78 has dimensions smaller than those of the needle stop 50. Consequently, at this point, the element is prevented needle holder 20 slide additionally distally with respect to the rod 34 of the needle, by virtue of the coupling of the needle stop 50 with the opening 78. Essentially anchored in the needle stop 50, any additional traction or force of extraction that is applied will cause the needle clamp element 20 deviate or bend around elongated elastic arms 43, 44 and to the front double or previous 60 points, which will make the elastic flanges 48 are mounted on the connection of Luer 70 in the proximal end 54 of the catheter receptacle 18. Finally as the needle 12 is removed beyond the proximal end of the catheter receptacle and pulls the elastic flanges 48 more beyond the Luer connection, the elastic arms 43, 44 adjust by elastic jump with each other when reaching its first position or relaxed position, so as to cause the walls transverse 46 close on the tip 26 of the needle and leave it locked (Figure 1d). In this locked position, a user or a practitioner is protected against accidental contact with the needle tip

While it is preferred that the needle stop 50 understand a lobe, due to its simple and cheap nature, the needle stop can be configured in any way suitable to prevent the needle 12 from disengaging or detaching completely of the needle clamp element 20. In embodiments alternatives, the needle stop 50 can be formed with the use of other techniques instead of by beading, for example, by attack electrochemical of the material located above and below the needle stop area, in order to reduce the diameter of the rest of the needle 12, or by milling needle 12 until obtaining the desired configuration. Both techniques provide the needle 12 an integral structure or configuration, which is what prefer. Other possible techniques include coating galvanic of the area that has been selected to be enlarged, the insert molding of a band of polymetric material around of the needle 12, or the welding of a metal band around the needle.

Referring to Figures 2a, 2b, 2e and 2f, an alternative embodiment of the set of catheter introduction according to the present invention. The barrier or lining 84 of needle tip or fastener safety elastic of this embodiment comprises arms elongated elastics 86 extending distally from the end wall 87 of the needle tip barrier. Getting back particularly to Figures 2e and 2f, at the ends of the arms elastic 86 are two portions of wall or elastic fingers 88, 90 transverse that extend inwards. The portions of transverse walls 88, 89 have generally shaped ends L and protruding inward, in the direction of the longitudinal axis of needle 12. In this embodiment, as best shown in the Figures 2d, 2e, 2f and 2g, the elastic security fastener 84 additionally comprises a pair of clamping arms 92, the which, as discussed further below, are designed to come into contact with both the terminal wrap 96 (located in the needle receptacle 14) as with the receptacle 18 of the catheter (Figure 2b). Elastic fingers 88, 90 and arms elastics 86 are in a relaxed or unloaded position, as shown in Figure 2f.

The end wall 87 of the fastener element safety elastic 84 has a retention cavity or a opening 78, located therein for the same limiting function which has been set forth in the foregoing for the embodiment described in relationship with Figures 1a-1e. The opening 78 is sized to allow the needle rod to travel to slip through it and fit with the needle stop 50, so retain the elastic fastener so that it is not dragged into distal direction outside the tip of the needle 12. The element elastic fastener 84 of this embodiment is configured such so that when the needle tip 26 moves in the direction proximal with respect to elastic fingers 88, 90, arms elastics 86 close elastically to allow fingers elastics 88, 90 move together to block the tip 26 of the needle.

Referring to Figure 2a, the set needle 94 comprises a needle receptacle 14 and a needle 12 arranged inside. Needle assembly 94 comprises additionally a modified section that includes the envelope terminal 96, which has, formed therein, a plurality of side slots 98. However, the number of side slots 98 can be reduced, or they can be eliminated in your whole.

The catheter body assembly 100 (Figure 2b) includes a pair of projections 102 that are Luer flanges or lugs fixation that act as anchor points and that are located in the proximal end of catheter receptacle 18. Like the Luer 70 thread steaks of the embodiment of Figure 1b, the projections 102 interact with the elastic fastener element of security 84 in order to detachably secure the receptacle 18 from catheter to needle receptacle 14, in ready position For operation. More specifically, the outgoing 102 interact with coupling portions 104 (Figure 2e) located in the clamping arms 92, in order to ensure detachable form the receptacle 18 from the catheter to the receptacle 14 of the needle, in the position ready for operation (Figure 2b). The projections 102 can also be connected to connectors conventional, such as intravenous binding device or similar element.

It is possible to arrange an alignment groove (not shown) in the terminal envelope 96, in order to guide the elastic security fastener element 84 inside the terminal wrap 96, such that the portions of needle clamp element coupling 104 (Figure 2e) is match the projections 102. Alternatively, the protrusions 102 can be provided in the form of a ring configured around the outer surface of the receptacle of the catheter, at its proximal end. In this case, the alignment groove, because, regardless of the orientation in which the elastic fastener element of security 84, the coupling portions 104 will be aligned With the ring

Like the embodiment illustrated in the Figures 1a-1d, the present embodiment has a pre-operative position (Figure 2a), an operative position or ready for operation (Figures 2b and 2c) and a position completely retracted (Figure 2g). The introduction set of Figure 2a-2g catheter works by inserting in first the tip 26 of the needle and the catheter 16, in the position ready for operation (Figures 2b and 2c), in a vein of a patient, and then removing the needle 12 while leave catheter 16 inserted in the vein. As the needle 12 gets withdraws from the patient, the holding arms 92 located in the elastic fastener element travel distally with with respect to the terminal wrap 96.

As the needle 12 is further removed of catheter 16, the elastic security fastener element 84, which it is still releasably coupled in the projections 102 of the catheter receptacle, slides distally with with respect to the needle rod 24, until the needle stop 50 is engages in the opening 78 in the elastic end wall 87. The elastic security fastener element 84 is prevented from being additionally move towards the tip of the needle, due to the coupling between opening 78 and needle stop 50. Tailored which is pulled further from the needle in the proximal direction, the additional tensile force makes the elastic fastener element 84 begin to separate from receptacle 18 of the catheter.

At this point, the clamping arms 92 are they deflect outward, being dragged beyond the ledges 102 located at the proximal end of catheter receptacle 18. Finally, as the needle 12 retracts or withdraws completely from catheter receptacle 18, clamping arms 92 are completely decoupled from protrusions 102, and tip 26 of the needle is dragged distally beyond the elastic fingers 88, 90, the elastic arms 86 are elastically closed until adopt your relaxed or relaxed position, and the elastic fingers are move together to block the needle tip. Is all place where the tip of the needle is blocked by the element elastic bra 84, as shown in Figure 2g.

In all the above embodiments described, each elastic security fastener element 20, 84, provided in accordance with the practice of the present invention, it works by blocking the tip 26 of the needle and being secured to the needle by means of two independent mechanisms. In a first mechanism, elastic fingers 46, 48 located in the element elastic safety bra 20, 84 are configured in such a way so that they move over the tip 26 of the needle, thereby they block the tip of the needle and prevent the displacement of the elastic fastener in the proximal direction, on the needle. In the second mechanism, the retention opening 78 located on the end wall 58, 87 is configured so that interact with the needle stop 50, so as to prevent the elastic fastener element is displaced out of the needle according to the distal sense.

Although they have been shown in Figures 1a to 2g and described above illustrative embodiments of the element elastic safety bra 20, it is possible to use in the present invention any suitable fastener design Elastic safety, as long as the fastener elastic works by blocking the tip 26 of the needle and cannot be accidentally decoupled from the needle tip once coupled. The elastic fasteners 20, 84 that have been described here are preferably manufactured with a construction or integral structure and stainless steel or other suitable material that have memory characteristics and elastic constant necessary.

Regardless of the specific embodiment to be used, by inserting the catheter assembly into a vein of a patient and remove the needle, the tip 26 of the needle is automatically locked by the elastic fastener element of safety with its complete separation of the catheter receptacle. The tip 26 of the needle is therefore passively blocked by the sliding action of the needle outside the implanted catheter. In others words, no independent step or action is required to specifically activate the elastic security fastener element. Therefore, the user is not required to perform any operation apart from those currently used when use needle catheter introduction devices conventional. The combined actions of the fastener elastic, elastic arms and needle stop allow the Elastic safety fastener element automatically attach to the tip of the needle and block it, once the catheter insertion procedure (i.e. once it has been the needle assembly fully retracted or removed). During the operation, there is only minimal friction coupling, or even there is no adverse friction between the fastener Elastic safety, the needle shank and the receptacle of the needle.

Referring below to the Figures 3a and 3b, the catheter assembly is shown therein as it has been described in relation to the embodiment of Figures 1a and 1b, if either the Luer 70 connection has been modified to include a connection 133. Connection 133 comprises a pair of thread fillets 132 that are interrupted by a pair of flat areas 143. Practiced by incision in flat areas 143, there are a couple of slots 137. Slots 137 are aligned perpendicular to fins 56 in Figure 3b, which is a view from one end, taken along the line D-D of Figure 3a.

In an embodiment provided by way of example, the needle receptacle 14 is fixed to the receptacle 15 of the catheter by first inserting needle 12 into the bore concentric of catheter 16, and then aligning so concurrent elastic flanges 48 (located in the element elastic security fastener 20) with slits 137 existing in the catheter receptacle, to continue with the needle insertion until the proximal end of the receptacle 15 of the catheter and the distal end of the needle receptacle 14 They bump into each other.

As can easily be understood by a person with ordinary knowledge of the technique, the receptacle 14 of the needle and catheter receptacle 15 may be configured in such a way that they match or fit in a way default In other words, it is possible to arrange a position ready for operation by which fins 56 remain aligned with a certain brand or label or design existing in the needle receptacle 14. In an embodiment that is provided to As an example, this can be achieved by configuring the slits 137 and thread steaks 132 so as to fit the element elastic security bra 20 such that, when the catheter receptacle 15 and needle receptacle 14 are rotated to match, the appearance is achieved at the end of the rotation / desired settings. In the embodiment shown in the Figure 3a, the complete rotation is configured in such a way that the elastic walls of distal end 46 are in a plane substantially parallel to the fins 56 existing in the catheter receptacle A physical stop or a tab (not shown), such that, when the tab of the catheter receptacle comes in contact with the eyelash of the needle receptacle, alignment is achieved.

Claims (4)

1. A catheter introduction unit, which understands: a needle receptacle (14) and a hollow needle (12) fixed to it, which is provided, near the tip of the needle, coupling means (50), a catheter receptacle (18), which comprises a catheter (16) attached thereto, a safety barrier or garrison (20; 110) for the tip of the needle, arranged around the needle and which is liable to slide from a position ready for operation to a safe position, in which the safety barrier covers the tip of the needle, and coupling means (58, 78), located in the safety barrier (20; 110), in which the coupling means (50) of the needle (12) are coupled with the coupling means (58, 78) arranged in the safety barrier (20; 110) when the needle is removed from the receptacle (18) of the catheter, such that the safety barrier adopts the safety position on the tip of the needle, in which the safety barrier has been realized as an elastic fastener element (28, 84), and in which elastic arms (43, 44) of this elastic fastener element cover the needle tip in the security position, characterized in that the elastic fastener element is arranged, at least in part, in the position ready for operation, within an enclosure wall or enclosure (66) of the needle receptacle (14), while the opposite elastic arms (43, 44; 92) of the elastic fastener element are detachably or detachably coupled to the outer circumference of the catheter receptacle (18). 2. A catheter introduction unit of according to claim 1, wherein the elastic arms (43, 44) covering the tip of the needle in the safe position they extend through elongated openings (36) of the wall of Evolvent (66) of the needle receptacle (14), in position ready for operation. 3. A catheter introduction unit of according to claim 1, wherein the fastener element elastic (84) is provided, in addition to the elastic arms (43, 44) covering the tip of the needle in the safe position of elastic arms (92) provided with coupling portions (104), which are removably coupled in the circumference outside the catheter receptacle (18), in the position ready for operation, while elastic arms (86) of elastic fastener provided to cover the tip of the needle, extend inside the catheter receptacle, in the position ready for operation. 4. A catheter introduction unit of according to claim 1, wherein a Luer connection (70) arranged in the outer circumference of the receptacle of the catheter has, in diametrically opposite positions, some areas flat (143) provided with grooves (137) for coupling with the elastic arms (43, 44).